A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS)

PHASE2CompletedINTERVENTIONAL
Enrollment

173

Participants

Timeline

Start Date

May 5, 2014

Primary Completion Date

May 4, 2016

Study Completion Date

May 4, 2016

Conditions
Down Syndrome
Interventions
DRUG

Placebo

Orally twice daily, 26 weeks

DRUG

RG1662

120 mg (80 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks

DRUG

RG1662

240 mg (160 mg for subjects 12 and 13 years of age) orally twice daily, 26 weeks

Trial Locations (37)

1142

Auckland Clinical Studies, Auckland

1426

Instituto Neurologia Bs As, Ciudad Autonoma de Bs As

6021

Wellington Hospital Research Office, Wellington

9016

University of Otago; Psychological Medicine Department, Dunedin

15706

Complejo Hospitalario Universitario de Santiago (CHUS); Area Asistencial Integrada de Pediatría, Santiago de Compostela

17090

UVaMID Hospital Santa Caterina;; Servicio de Neurología, Salt

20030

Clínica Para la Atención del Neurodesarrollo, Aguascalientes

21287

Johns Hopkins Hospital., Baltimore

27710

Duke Clin Rsch Institute, Durham

28006

Hospital Universitario de la Princesa; Medicina Interna, Madrid

28009

Hospital Infantil Universitario Niño Jesus; Pediatria Social, Madrid

28016

Fundación Síndrome de Down; Fundación Síndrome de Down, Madrid

30033

Emory University School of Medicine; Department of Human Genetics & Pediatrics, Decatur

34295

CHU de Montpellier Hopital Arnaud de Villeneuve; de Génétique, Montpellier

42055

CHU de Saint Etienne; Service de Génétique, Saint-Etienne

45200

Hospital Dr. Angel Leaño; Pediatria, Guadalajara

53705

University of Wisconsin Madison, Waisman Center, Madison

60612

Rush University Medical Center, Chicago

64460

Hospital Universitario Dr. Jose Eleuterio Gonzalez; Pediatria, Monterrey

69003

Groupement Hospitalier Est-Hopital Femme Mere enfant/Hospice civils de lyon, Bron

75015

Institut Jérôme Lejeune; Neuropsychology, Paris

76000

Hospital Médica Tec 100, Querétaro

84112

University of Utah School of Medicine; Department of Pediatrics, Salt Lake City

92037

Univ of CA San Diego; Neurosciences Comp.Alzheimer's, La Jolla

95817

University of California DAVIS Medical Center; M.I.N.D. Institute, Section of Developmental Behavior, Sacramento

229899

KK Women's and Children's Hospital; Department of Neonatology, Singapore

02114

Massachusette General Hospital; Medical Genetics, Boston

C1428AQK

FLENI, CABA

B4N 4K9

True North Clinical Research Kentville, Kentville

00165

Ospedale Pediatrico Bambino Gesù, Rome

00168

"Policlinico Universitario Agostino Gemelli;Dip. Tutela Salute Donna Bambino Adolescente", Rome

09121

Ospedale Microcitemico; Clinica Pediatrica, Cagliari

08009

IMIM, Human Pharmacology and Clinical Neurosciences,, Barcelona

Unknown

Blackpool Teaching Hospitals NHS Foundation Trust; Child Development and Family Support Centre, Blackpool

DA2 6PB

Mental Health of Learning Disability, Kent & Medway NHS and Social Care Partnership Trust, Dartford, Kent

DN2 5LT

Doncaster and Bassetlaw Hospitals NHS Foundation Trust; Doncaster Royal Infirmary, Doncaster

TR15 2SP

Cornwall Partnership NHS Foundation Trust, Redruth

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY

NCT02024789 - A Study of RG1662 in Adults and Adolescents With Down Syndrome (CLEMATIS) | Biotech Hunter | Biotech Hunter